Composition comprising viscous fibers and viscosity-lowering proteins

ABSTRACT

The invention concerns compositions comprising one or more viscous soluble fiber(s) and one or more viscosity-lowering protein(s) and their use in the prevention or treatment of metabolic syndrome and/or diabetes and/or for lowering blood cholesterol level.

The present invention concerns a viscous soluble fiber composition. Theinvention also relates to a method for modulating the viscosity of aviscous soluble fiber composition and to a method for preventing ortreating diabetes, hypercholesterolemia, obesity, and/or metabolicsyndrome in a mammal.

The importance of dietary fiber in the daily diet has been emphasizedover the last several years through the recognition of its effects inthe prevention and/or treatment of such diseases as hyperlipidemia,coronary heart disease, arteriosclerosis, colon diverticulum, coloncancer, heart diseases, hypercholesterolemia, obesity, hypertension,diabetes or metabolic syndrome. Metabolic syndrome can be characterizedby at least one of the following abnormalities: abdominal obesity,hyperlipidemia, hypercholesterolemia, high blood pressure and high bloodglucose level. Recent studies have shown that more than 20% of the USadult population has the metabolic syndrome.

Soluble fibers act in promoting bowel action. The bulk-forming propertyof such fiber also contributes to fill the stomach, which has a satietyeffect. Soluble fibers delay the emptying of the stomach and slow thetransit of chyme in the upper gastrointestinal tract, resulting inslower absorption rates and altered hormonal responses to the absorbednutrients. It has been proposed that viscous soluble fibers, such askonjac gum or oat beta glucan, may reduce the need for insulin, improveglycemia, reduce serum (LDL) cholesterol, slow the appearance of glucosein the blood and inhibit bile acid absorption in the ileum.

A potential difficulty in adopting viscous soluble fiber in acomposition is the viscosity that is generally associated with levelsconsidered to be therapeutic in the treatment of certain diseases, suchas diabetes or metabolic syndrome. In particular, the high viscosity mayrender problematic the preparation of a composition for oral and enteraladministration, especially for patients requiring tube-feeding.Therefore there is a need for a viscous soluble fiber composition, whichis non-viscous, i.e. sufficiently low viscous to be enterally and/ororally administered.

Present inventors have surprisingly found that proteins, such as wheatprotein, egg protein, collagen protein, whey protein, casein protein,gluten, pea protein and/or hydrolysates thereof, have the ability tolower the viscosity of viscous soluble fiber compositions, such askonjac gum and/or xanthan gum and/or guar gum and/or beta glucan and/orpectin compositions. According to the invention nutritional compositionscomprising high level of high viscous soluble fiber may be formulated,which are convenient to administer, yet without necessarily increasingthe glucidic value of such compositions. After ingestion, the viscosityof the soluble fibers comprised in the compositions according to theinvention may re-increase because of the digestion and the consecutivehydrolysis of the viscosity-lowering protein.

In a first aspect of the invention there is provided a compositioncomprising one or more viscous soluble fiber(s) and one or moreviscosity-lowering protein(s), hereinafter referred to as composition ofthe invention.

In another aspect of the invention there is provided a composition ofthe invention for use as a medicament.

In a further aspect of the invention there is provided a composition ofthe invention for use in meeting the dietary fiber intake of a mammal.

In yet another aspect of the invention there is provided a use of thecompositions of the invention in the manufacture of a medicament ornutritional composition for the prevention or treatment of metabolicsyndrome and/or diabetes, and/or for lowering blood cholesterol level.

In another aspect of the invention there is provided a method oftreating and/or preventing diabetes and/or metabolic syndrome and/or oflowering blood cholesterol level in a mammal in need of such a treatmentcomprising administering to said mammal an effective amount of acomposition of the invention.

In a further aspect of the invention there is provided a method forproviding viscous soluble fibers to a mammal in need of such fiberscomprising administering to said mammal a composition of the invention.

In another aspect of the invention there is provided a use of protein tomodulate the viscosity of a composition comprising one or more viscoussoluble fiber(s), wherein said protein is selected from the groupconsisting of wheat protein, egg protein, collagen, whey protein,casein, soy protein, pea protein, muscle protein, gluten, fibrillarprotein, silk protein, hydrolysates thereof and mixtures thereof.

The term “soluble fiber” as used herein refers to non-starchpolysaccharides characterized as being soluble by using the officialmethod of the Association of Official Analytical Chemists (Prosky et al,1988; J. Assoc. Off Anal. Chem, 70, 5, 1017), e.g. water soluble fibers,e.g. water soluble at room temperature.

As used herein, the term “viscous fiber” refers to fibers which are ableto increase the viscosity of the contents of the stomach and the smallintestine and to slow gastric emptying rates. Typically, compositionscomprising 1% by weight of such viscous fibers have a viscosity higherthan about 500 mPa·s (500 centipoises) at room temperature, e.g.temperature from 20° C. to 25° C., e.g. more than about 1000 mPa·s, ormore than about 1500 mPa·s. In one aspect of the invention, such viscousfibers have a molecular weight between about 20'000 and about 5 millionsDa, e.g. between about 100'000 and about 2 millions Da.

As used herein, the term “dietary fiber” refers to non-starchpolysaccharides non hydrolyzed, or only partially hydrolyzed, by thehuman digestive enzymes. These polysaccharides may contain beta 1,4 orbeta 1,6 bonds.

For the purpose of the present invention, the term “compositions of theinvention” encompasses compositions comprising viscous soluble fiber,e.g. viscous soluble dietary fiber, and viscosity-lowering protein, e.g.for oral or enteral administration. Such compositions may benon-viscous, e.g. less viscous than same compositions in which theviscosity-lowering protein is absent, and/or hydrolyzed, e.g. moderatelyor extensively hydrolyzed. In another aspect of the invention, thecompositions according to the invention, e.g. the non-viscouscompositions of the invention, may be defined by a viscosity less thanabout 500 mPa·s, e.g. less than about 250 or less than about 150 mPa·s,e.g. less than about 100 mPa·s or less than about 60 mPa·s. In oneaspect the compositions of the invention may have a viscosity of betweenabout 60 and about 500 mPa·s at room temperature. It has to beunderstood that such viscosities are measured with a Brookfield LVDV IIviscosimeter at room temperature, e.g. temperature from 20° to 25° C.,and for a spindle and a shear rate in agreement with the productthickness. For example, viscosities lower than 60 mPa·s are measuredwith a LVDV II viscosimeter having a spindle of 1 and at 100 rotationsper minute (rpm).

The compositions of the invention have the advantageous characteristicthat the viscosity may be modulated, for example reversed, delayed, orre-increased. As used herein, “modulated viscosity” refers to theviscosity of a soluble viscous fiber composition that has beenmodulated, i.e. lowered, or totally or partially re-increased, e.g. bymoderately or extensively hydrolyzing the viscosity-lowering protein. Asused herein, “delayed viscosity” refers to the viscosity of compositionsof the invention which has been re-increased, e.g. by moderately orextensively hydrolyzing the viscosity-lowering protein, or by denaturingthe viscosity-lowering protein. As used herein, “moderately hydrolyzedprotein” refers to protein which has a molecular weight between about 1and about 20 kDa, e.g. between about 5 and about 15 kDa. As used herein,“extensively hydrolyzed protein” refers to protein which has a molecularweight lower than about 0.5 kDa, e.g. lower than 0.2 kDa or lower thanabout 0.1 kDa. As used herein, “denatured protein” refers to proteinhaving no further viscosity lowering activity in the composition towhich it is added or in which it is present. The hydrolysis ordenaturation of the viscosity-lowering protein may occur in vivo, i.e.after ingestion of the compositions of the invention, e.g. non-viscouscompositions, converting the compositions of the invention from low- ornon-viscous to high-viscous compositions, resulting in e.g. a slowerglucose absorption and/or in a lower or slower glucose and insulinresponse to carbohydrate loads. In one aspect of the invention, there isprovided a composition comprising viscous soluble fiber(s) andviscosity-lowering protein(s) wherein the viscosity-lowering effect ofthe protein, e.g. the viscosity of the composition, is reversible.

In one embodiment of the invention, compositions of the invention mayconsist exclusively or essentially of viscous soluble fiber, e.g.viscous soluble dietary fiber, and viscosity-lowering protein.Alternatively, the compositions of the invention may comprise othernutritional and/or pharmaceutical components in addition to viscoussoluble fiber and viscosity-lowering protein.

Examples of suitable viscous soluble fibers according to the presentinvention include agar, alginates, carubin, pectin, beta-glucan, such asoat beta-glucan, carrageenans, furcellaran, inulin, arabinogalactan,pectin and its derivatives, cellulose and its derivatives, scleroglucan,psyllium, such as psyllium seed husk mucilages and gums. In the contextof the present invention the term “pectin” refers preferably to pectinsfrom fruits and vegetables, and more preferably to pectins from citrusfruits and apple. The term “carrageenans” as used herein encompasses inparticular kappa, lambda and iota carrageenans. According to theinvention, gums and mucilages are preferably plant exudates. Inparticular, the term “gum” as used herein refers to the commonlyavailable vegetable gums and more particularly to konjac gum, xanthangum, guar gum, e.g. Guaran gum, locust bean gum, tara bean gum, gumtragacanth, arabic gum, karaya gum, gum ghatti, gellan gum and otherrelated sterculia gum, Alfalfa, Clover, Fenugreek, Tamarind flour.Native and modified, e.g. hydrolyzed, in particular moderatelyhydrolyzed, soluble viscous fibers, especially gum arabic, may be usedaccording to the invention. According to the invention, the preferredviscous fibers are xanthan gum, pectin, guar gum, beta glucan, konjacgum, and any mixtures thereof.

In one embodiment of the invention, the compositions of the invention donot comprise hydrolyzed, e.g. extensively hydrolyzed, soluble viscousfiber. As used herein, “hydrolyzed, e.g. extensively hydrolyze, solubleviscous fiber” refers to non-viscous soluble fiber, e.g. having amolecular weight between about 300 and about 20'000 Da, e.g. betweenabout 500 and about 10'000 Da. In another aspect of the invention, thecompositions of the invention may comprise native guar gum, xanthan gum,beta glucan and/or konjac gum. Optionally the compositions according tothe invention may comprise moderately hydrolyzed soluble viscous fiber,e.g. moderately hydrolyzed xanthan gum, beta glucan, konjac gum, guargum or any combination thereof. As used herein, “moderately hydrolyzedviscous fiber” refers to fibers having a molecular weight between about20'000 and about 5 millions Da, e.g. between about 100'000 and about 2millions Da.

The fiber of the compositions of the invention may consist essentiallyor exclusively of viscous soluble fibers, e.g. viscous soluble dietaryfibers, optionally in the form of native viscous soluble fibers, or inthe form of moderately hydrolyzed viscous soluble fiber, or mixturesthereof. In a further embodiment of the invention, the compositions ofthe invention do not comprise non-viscous soluble fiber. In yet afurther embodiment of the invention, the compositions of the inventiondo not comprise inulin.

The compositions of the invention may comprise one viscous solublefiber, preferably konjac gum, xanthan gum, guar gum, beta-glucan orpectin, even more preferably guar gum. In another embodiment of theinvention, the compositions according to the invention may comprise amixture of viscous soluble fibers, preferably a mixture of guar gum andone or more viscous soluble fibers selected from the group consisting ofpectin, beta-glucan, xanthan gum, arabic gum, carageenan and konjac gum,more preferably a mixture of guar gum and one or more viscous solublefibers selected from the group consisting of xanthan gum and konjac gum,and even more preferably a mixture of guar gum and xanthan gum.

Xanthan gum, the extracellular polysaccharide from Xanthomonascampestris and some related microorganisms, is produced on a nutritivemedium comprising glucose, a nitrogen source and minerals. It is used inthe food industry as a stabilizer or thickener. It is also known tointeract synergistically with other hydrocolloids like guar gum. Xanthangum is commercially available from Satiaxane CX2QD, Degussa TexturantSystem, France.

Konjac glucomannan, also called konjac mannan or konjac gum, has thehighest viscosity of any dietary fiber known. Konjac gum has a highcapacity for water absorption and can swell to about 200 times itsoriginal volume. In food industry, konjac gum is often added to starchbecause their interaction leads to a considerable increase in theviscosity and to the formation of gel, which can be maintained duringcooking. Konjac gum is also known to interact synergistically withhydrocolloids such as kappa-carrageenan, xanthan gum or locust bean gumto form heat-stable gels. Konjac gum may also gel by itself if heatedafter alkali addition. According to the present invention, konjac gummay be extracted from the Amorphopallus species, more particularly fromA. riviera often referred to as A. konjac), A. oncophyllus, A. variais,A. bulbifera and A. blumeli, more preferably from A. riviera, and evenmore preferably from A. riviera C. Koch. In particular konjac gum isproduced from the root of the plant Amorphopallus, and more preferablyfrom the tuber thereof. Konjac flour may be prepared by drying,pulverizing and winnowing the plant. Several techniques are known in theart for separating konjac glucomannan from konjac flour. As used hereinthe term “konjac gum” encompasses konjac glucomannan and konjac flour.The konjac gum is commercially available from Propol RS, Shimizu, Japan.

Guar Gum is obtained from the seed endosperms of the leguminous plantCyamopsis tetragonolobus (Linné) Taub. and consists mainly of a highmolecular weight hydrocolloidal polysaccharide, composed of galactoseand mannose units combined through glycoside linkages. Guar Gum is usedin the food industry as a stabilizer or thickener. It is also known tointeract synergistically with other hydrocolloids like xanthan gum. Guargum is commercially available from Polygum 75, Polygal AG, Switzerland(high molecular weight type) and from Lygomme 3, Degussa TexturantSystems, France (low molecular weight type). As used herein, the term“guar gum” encompasses high molecular weight type and low molecularweight type.

Mixed-linkage (1→3)(1→4)-β-D-glucan (beta-glucan) is the mainendospermic cell wall polysaccharide of oats and barley, but alsopresent, in lesser amounts, in rye and wheat. The subaleurone andsubembryo layers of dehulled oat are particularly rich in beta-glucan,whereas in the inner starchy endosperm concentrations are low.Beta-glucan can therefore be enriched in bran fractions by 3-4 times.Beta-glucan is commercially available from Megazyme International,Ireland.

Pectin is a purified carbohydrate product obtained from the dilute acidextract of the inner portion of the rind of citrus fruits or from applepomace. It consists mainly of partially methoxylated polygalacturonicacids. It is commercially available from Riedel de Haen AG, Germany.

Details of the active ingredients of the compositions of the inventionmay be obtained from the relevant manufacturers the contents of whichare hereby incorporated by reference.

The relative proportion of the active ingredients of the compositions ofthe invention will, of course, vary considerably depending on theparticular type of composition concerned, e.g. whether it is a liquid orsolid form, or whether it is provided in nutritional form. All indicatedproportions and relative weight ranges described below are accordinglyto be understood as being indicative of preferred or individuallyinventive teaching only and not limiting the invention in its broadestaspect.

According to the present invention, the term “soluble viscous fiber” isreferred to as fiber concentrate or not pure fiber source. Fiberconcentrates may be pectin and gum, more preferably gum arabic, locustbean gum, guar gum, psyllium seed husk. Fiber concentrate of theinvention may comprise more than 90% by weight of fiber, based on thetotal dry weight of the fiber concentrate, preferably more than 95% byweight. Not pure fiber source may comprise more than 80% by weight offiber.

Furthermore the compositions of the invention may comprise insolublefibers, such as cellulose, hull fibers from legumes and grains, such aspea hull fiber, oat hull fiber, barley hull fiber, soy hull fiber. Inone embodiment of the invention, the ratio of soluble viscous fiber toinsoluble fiber may be from 0.1 to 10, preferably from 0.2 to 5.

The term “viscosity-lowering protein” as used herein refers to proteinsor peptides which when added to a viscous soluble fiber composition maylower the viscosity of that composition. According to the presentinvention these proteins may have a molecular weight lower than about 35kDa, more preferably lower than about 30 kDa, even more preferably fromabout 0.2 to about 30 kDa, and even more preferably from about 1 toabout 25 kDa. These values refer to an approximate molecular weightrange with values falling above and below the given range. Theviscosity-lowering proteins of the invention may be in the form ofnative protein or in form of hydrolysate.

Examples of “viscosity-lowering protein” according to the presentinvention include wheat protein, soy protein, pea protein, egg protein,collagen, whey protein, casein, gluten, muscle proteins from fish andanimals, fibrillar proteins, silk proteins, e.g. keratin, sericin orfibroin, and mixtures thereof. Accordingly, in one aspect the presentinvention provides compositions comprising wheat protein, egg protein,collagen, whey protein, casein, soy protein, pea protein, fibrillarproteins, silk proteins, e.g. keratin, sericin or fibroin, hydrolysatesthereof or mixtures thereof, preferably wheat protein, egg protein,collagen, fibrillar proteins, silk proteins, e.g. keratin, sericin orfibroin, hydrolysates thereof or mixtures thereof. In another aspect thepresent invention provides compositions of the invention comprising wheyprotein, casein, soy protein, pea protein and/or hydrolysate thereof,with the proviso that said compositions do not comprise inulin.

In another aspect of the invention, there is provided a composition ofthe invention wherein the composition does not comprise phytoestrogen ora xanthine derivative. In one embodiment of the invention, there isprovided a composition of the invention comprising soy protein and/orhydrolysate thereof, with the proviso that said composition does notcomprise phytoestrogen or a xanthine derivative.

In yet another aspect of the invention, there is provided a compositionof the invention comprising viscous soluble fiber selected from thegroup consisting of xanthan gum, arabic gum, guar gum, pectin,beta-glucan, and mixtures thereof, with the proviso that saidcompositions do not comprise inulin.

In a further embodiment of the invention, the compositions of theinvention may comprise a viscous soluble fiber selected from the groupconsisting of gum, mucilage, carrageenan, and mixtures thereof,preferably a viscous soluble fiber selected from the group consisting ofkonjac gum, locust bean gum, tara bean gum, gum tragacanth, karaya gumand mixtures thereof.

In yet a further embodiment of the invention, the compositions of theinvention may comprise guar gum, xanthan gum, konjac gum, pectin and/orbeta-glucan in combination with a viscosity-lowering protein selectedfrom the group consisting of wheat protein, egg protein, collagen, peaprotein, fibrillar proteins, silk proteins, e.g. keratin, sericin orfibroin, hydrolysates thereof and mixtures thereof.

In another embodiment of the invention, the compositions of theinvention consist essentially of, or exclusively of, guar gum andcollagen hydrolysate.

In another aspect of the invention, there is provided a composition ofthe invention comprising a viscosity-lowering protein which has beenhydrolyzed, e.g. moderately or extensively hydrolyzed, e.g. a proteinhaving no, e.g. substantially no, further viscosity-lowering activity.It will be appreciated that according to the invention one or a mixtureof viscosity-lowering protein(s) may be used.

The amount of viscous soluble fiber incorporated into the compositionsof the invention may depend on the nature and/or the molecular weight ofthe viscous fiber, the nature and the amount of the viscosity-loweringprotein, the form of the compositions of the invention, e.g. a powder ora composition ready-for-consumption,—e.g. ready-to-drink composition orinstant drink—, or on the final viscosity to be reached, e.g. the typeof product in which the compositions will be incorporated. Typically,the more viscous the viscous soluble fiber is, the less it amounts inthe compositions.

Accordingly, suitable amounts of viscous soluble fiber comprised inready-for-consumption compositions according to the invention are in therange of up to about 40% by weight, e.g. up to about 20% by weight, orup to about 15% by weight, for example from about 0.05 to about 10% byweight, e.g. from about 0.5 or 1 to about 2.5, 5 or 10%, e.g. about 1%by weight, based on the total weight of the ready-for-consumptioncomposition.

The compositions of the invention in powder form may comprise viscoussoluble fiber in an amount of about 0.5 to about 60% by weight, morepreferably in an amount of about 4 to about 40% by weight, morepreferably in an amount of about 10 to about 30% by weight and even morepreferably in an amount of about 8 to about 20% by weight, based on thetotal weight of the powder composition.

In one preferred embodiment of the invention, the compositions accordingto the invention, the weight ratio of xanthan gum to konjac gum is fromabout 0.5 to about 10, more preferably from about 1 to about 5, and evenmore preferably from about 2 to about 4. In another embodiment of theinvention, the weight ratio of guar gum to xanthan gum of thecompositions of the invention is from about 0.01 to about 100, morepreferably from about 0.05 to about 10, and even more preferably fromabout 0.1 to about 5.

The suitable amount of viscosity lowering-proteins incorporated into thecompositions of the invention may depend on the molecular weight and/oron the nature of the protein, for example on its three-dimensionalstructure, e.g. globular, fibrillar, denaturated structure, its charge,or its pHi.

The amount of viscosity-lowering protein incorporated into theready-for-consumption compositions of the invention may vary from about1 to about 60% by weight, preferably from about 2 to about 20% byweight, more preferably from about 3 to about 10% by weight, even morepreferably from about 4 to about 8% by weight, based on the total weightof the composition.

In one embodiment of the invention, the compositions of the invention inpowder form comprise an amount of viscosity-lowering protein from about0.05 to 90% by weight, preferably from about 0.5 to about 80% by weight,more preferably from about 20 to about 60% by weight of the composition,based on the total weight of the composition.

In a further aspect of the invention, the compositions of the inventionmay comprise the viscosity lowering-protein in an amount sufficient toprovide a non-viscous composition, e.g. for oral or enteraladministration, e.g. a composition having a viscosity lower than 500mPa·s.

In another embodiment of the invention, the weight ratio of viscoussoluble fiber:viscosity lowering-protein in the compositions of theinvention, in powder or in ready for consumption form, may be from about0.01:1 to about 20:1, preferably from about 0.05:1 to about 10:1, morepreferably from about 0.1:1 to about 1:1, and most preferably from about0.1:1 to about 0.4:1.

In one aspect of the invention, the total amount of viscous solublefiber and viscosity lowering-protein in the compositions of theinvention, in powder or in ready for consumption form, may be from about1 to about 65% by weight, more preferably from about 1 to about 30% byweight, even more preferably from 2 to 15% by weight and most preferablyfrom about 5 to about 15% by weight, based on the total weight of thecomposition.

In one embodiment of the invention, the compositions of the inventionmay comprise other proteinaceous material in addition to the viscositylowering-protein. “Proteinaceous material” as used herein refers to anyform of protein, peptide, free amino acid, mixtures of amino acids, andcombinations thereof.

In a further embodiment of the invention, the compositions of theinvention may comprise, in addition to soluble viscous fiber andviscosity lowering-protein, other nutritional components like fat,carbohydrate, minerals and vitamins, for example, among others, calcium,magnesium, iron, zinc, phosphorus, vitamin D and/or vitamin K.

In another embodiment of the invention, the carbohydrate content of thecompositions according to the invention, including viscous solublefiber, may be less than about 60 en %, preferably less than about 55 en%, more preferably less than about 30 en %, most preferably less thanabout 20 en %, based on the total caloric content of the composition.

In yet another embodiment of the invention, the compositions accordingto the invention may not comprise starch-derived carbohydrates, such asmaltodextrin, modified starch, amylose starch, topioca starch, cornstarch, or mixtures thereof.

In another embodiment of the invention, the compositions according tothe invention may not comprise saccharose.

In a further embodiment of the invention, the compositions according tothe invention may comprise fructose and/or galactose.

Further components of the compositions according to the invention mayinclude any bioactive compounds or extracts which are known to havehealth benefits, especially for lowering blood cholesterol level inmammals, such as statins, bile acid sequestrants, nicotinic acid orfibric acids, and/or for treating diabetes, such as sulfonylureas,biguanides, alpha-glucosidase inhibitors, thiazolidinediones,meglitinides or D-phenylalamine. For example, the composition of theinvention may be provided in the form of a kit for separate, sequentialor simultaneous administration in conjunction with such medicines forlowering blood glucose and/or blood cholesterol level. These medicinesmay conveniently be formulated together with viscous soluble fiber, suchas e.g. konjac gum, xanthan gum, beta-glucan or guar gum, and aviscosity-lowering protein in standard pharmaceutical dosage forms.

In one aspect of the present invention, the compositions according tothe invention can readily be incorporated into pharmaceutical ornutritional formulations, typically nutraceuticals, dietary supplements,functional food and beverage products.

In a further aspect of the invention, the compositions of the inventionmay be used as a medicament. Accordingly the compositions of theinvention may be administered in pharmaceutical form or as a dietarysupplement, preferably in combination with at least one pharmaceuticallyor nutritionally acceptable carrier.

In a yet further aspect of the invention, there is provided amedicament, nutritional or pharmaceutical formulation, for exampledietary supplement, comprising the composition of the invention. Themedicament, nutritional or pharmaceutical composition of the inventionmay optionally comprise pharmaceutical acceptable carriers. Further,according to the invention there is provided a combined pharmaceuticalpreparation for simultaneous, separate or sequential use for thetreatment or prevention of diabetes comprising soluble viscous fiber andviscosity-lowering protein and one or more drug(s) for lowering bloodglucose and/or one or more drug(s) for lowering blood cholesterol level.

Pharmaceutical compositions and dietary supplements may be provided inthe form of soft gel, sachets, powders, syrups, liquid suspensions,emulsions and solutions in convenient dosage forms. In soft capsules theactive ingredients are preferably dissolved or suspended in suitableliquids, such as fatty oils, paraffin oil or liquid polyethyleneglycols. Optionally stabilisers may be added.

Oral pharmaceutical or dietary supplement forms may be made byconventional compounding procedures known in the pharmaceutical art,that is, by mixing the active substances together with ediblepharmaceutically acceptable solid or liquid carriers and/or excipients,e.g. fillers such as cellulose, lactose, sucrose, mannitol, sorbitol,and calcium phosphates and binders, such as starch, gelatin, tragacanth,methylcellulose and/or polyvinylpyrrolidone (PVP). Optional additivesinclude lubricants and flow conditioners, e.g. silicic acid, silicondioxide, talc, stearic acid, magnesium/calcium orates, polyethyleneglycol (PEG) diluents, disintegrating agents, e.g. starch, carboxymethylstarch, cross-linked PVP, agar, alginic acid and alginates, colouringagents, flavouring agents, and melting agents. Dyes or pigments may beadded to the tablets or dragée coatings, for example for identificationpurposes or to indicate different doses of active ingredient.

Optionally, the compositions according to the invention may benutritionally complete, i.e. may include vitamins, minerals, traceelements as well as nitrogen, carbohydrate and fatty acid sources sothat they may be used as the sole source of nutrition supplyingessentially all the required daily amounts of vitamins, minerals,carbohydrates, fatty acids, proteins and the like. Accordingly, thecompositions of the invention may be provided in the form of anutritionally balanced complete meal, e.g. suited for oral or tubefeeding.

Alternatively, the compositions of the invention may be provided as partof a meal, i.e. a nutritional supplement, e.g. in the form of a drink,e.g. a health drink.

In another aspect of the invention, there is provided a method to meetthe dietary fiber intake of a mammal, comprising administering to amammal in need thereof a composition of the invention.

It may be desirable to provide the soluble viscous fiber in the form ofa low calorie meal replacement or other nutritional product. In thiscase the meal replacement or other nutritional product is preferably lowfat, i.e. less than about 10 en %, or substantially fat-free, i.e. lessthan about 2.5 en % contributed by fat, such as about 2 en % fat, basedon the total caloric content of the composition. Suitably, a singleserving of a low calorie meal replacement will have a caloric value ofless than about 1000 kcal, and preferably between about 200 kcal andabout 500 kcal. Suitable low calorie nutritional product may includesoft drink, such as juice, smoothie or soy-based drink, or dispersed infoods of any sort, such as, dairy bars, soups, breakfast cereals,müesli, candies, tabs, cookies, biscuits, crackers, such as a ricecrackers, and dairy products, such as milk-shake, yoghurt drink.

The compositions of the invention optionally comprise conventional foodadditives, such as any of emulsifies, stabilizes, sweeteners,flavourings, colouring agents, preservatives, chelating agents, osmoticagents, buffers or agents for pH adjustment, acidulants, thickeners,texturisers, and so on.

In a further aspect of the invention, there is provided a use ofcompositions of the invention as food additive.

The method of modulating, i.e. increasing or decreasing, the viscosityof the compositions of the invention may be advantageous in thepreparation of food products and beverages. For example, thecompositions of the invention, e.g. low viscous compositions, may beused for preparing a high viscous nutritional product. The compositionsof the invention may also be used to modify the viscosity, to stabilizeand/or to texturize food and beverage products, such as ice creams,candies, chocolates, müesli, cookies, biscuits, crackers, chewing-gums,dairy products, desserts, milk-shakes, yogurt drinks, soups and thelike. Optionally the compositions of the invention may be used as a fatsubstitute in a variety of reduced fat, low fat and fat free foods andbeverages, such as cakes, pudding type desserts, butter, peanut butter,cheeses, salad dressings, sauces, margarine, cream cheese and otherspreads, snack dips, mayonnaise, sour cream, yogurt, ice cream, frozendesserts, fudge and other confections, and skim milk. The compositionsof the invention are also useful, for example as a shortening, in bakedgoods such as cakes, pies, brownies, cookies, breads, noodles, snackitems, such as crackers, graham crackers and pretzels, and similarproducts.

Suitable product formats according to the present invention includesolution, ready-for-consumption composition, e.g. ready-to-drinkcompositions, instant drink, liquid comestibles, like soft drinks,juice, sports drinks, milk drinks, milk-shakes, yogurt drinks or soup.In a further embodiment of the invention, the compositions of thepresent invention may be manufactured and sold in the form of aconcentrate, a powder, or granules, e.g. effervescent granules, whichare diluted with water or other liquid, such as milk or fruit juice, toyield a ready-for-consumption composition, e.g. ready-to-drinkcompositions or instant drink.

Enteral administration of the compositions of the invention, andpreferably oral administration are covered by the present invention.

The amount and dosage regimen of the compositions of the invention to beadministered is determined in the light of various relevant factorsincluding the purpose of administration, the age, sex and body weight ofindividual subject and the severity of the subject's symptoms.

When the composition according to the invention is supplied in the formof a food or beverage, a suitable serving size of the composition may befrom about 20 to about 500 g, preferably from about 30 to about 300 g.If provided in pharmaceutical form, suitable daily doses of thecomposition of the invention are up to about 250 g, preferably 150 g,and optimally in the range of about 10 to about 100 g. In terms of bodyweight, an appropriate daily dosage range is about 2 to about 15 gcomposition of the invention per kg. The daily dosage may correspond toa single unit dosage, or may be provided through multiple unit dosages.The exact amounts of the compositions according to the invention mayvary between wide limits and may be readily determined in conventionalmanner.

The compositions of the invention, e.g. medical or nutritionalformulations comprising the compositions of the invention, have theadvantageous characteristic of decreased viscosity, thus allowingdelivery of an effective amount of viscous soluble fibers. Suitabledaily doses of viscous soluble fiber according to the invention are inthe range of about 2 mg to about 50 g, preferably in the range of about25 mg to about 40 g, more preferably in the range of about 50 mg toabout 30 g and most preferably in the range of about 2 g to about 20 g.

The compositions of the invention may be administered under thesupervision of a medical specialist, or may be self-administered.

The compositions of the invention may be administered daily, weekly ormonthly, or may be administered annually or even for longer periods inorder for example to constantly control the glucose or cholesterol bloodlevel of a patient suffering from diabetes or high blood cholesterollevel. Suitable daily dosage regimen may include single or multipleservings per day. Optimally, the composition of the invention isconsumed at least once a day on a regular basis, prior to, i.e. pre- orpost-prandial, or during a meal. Preferably, the compositions of theinvention may be consumed prior to a meal. In one embodiment of theinvention, the composition of the invention may be taken until forexample a blood glucose level of 180 mg/dL or less, 2 hours after meals,has been resumed, or until a blood cholesterol level of 200 mg/dL orless has been obtained, and/or a blood LDL cholesterol level of lessthan 160 mg/dL, or less than 130 mg/dL has been resumed. Since theseformulations are safe to consume, subjects with diabetes, metabolicsyndrome and/or hypercholesterolemia can continue taking compositionaccording to the invention for as long as required, and preferably untilnormal blood glucose level, 2 hours after meals, and/or cholesterollevel has been resumed.

Pharmaceutical, food or beverage incorporating compositions according tothe invention can be safely-consumed by anyone, and are especiallyrecommended for anyone perceived to be at risk fromhypercholesterolemia, diabetes or metabolic syndrome, such as elderly,smokers and/or anyone suffering from overweight, obesity, heart diseaseor high blood pressure. The compositions of the invention may beparticularly suitable for subjects suffering from metabolic syndrome,blood sugar disorders, arteriosclerosis, hypertension,hypercholesterolemia, hyperlipidemia, diabetes, intestinal or digestivetroubles, Crohn's disease, Irritable Bowel Syndrom (IBS), InflammatoryBowel Disease (IBD), intestinal diverticula, carcinoma of colon. Bylowering blood glucose level, the compositions of the invention havealso the effect of counteracting the sequelea of heart disease, highblood pressure, stroke, blindness, blood vessel disease, kidney failure,amputation and nerve damage. “High blood pressure” as used herein refersto a blood pressure persistently exceeding 140/90 mmHg(systolic/diasystolic). By lowering blood cholesterol level, thecompositions of the invention may also prevent heart diseases, e.g.heart attacks.

In one embodiment of the invention, the invention pertains to a methodof treating and/or preventing metabolic syndrome and/or diabetes and/orhypercholesterolemia, in a mammal, including human, in need of such atreatment, comprising administering to said mammal an effective amountof a composition according to the invention. As used herein, the term“an effective amount” refers to an amount effective to achieve a desiredtherapeutic effect, such as treating and/or preventing diabetes and/ormetabolic syndrome and/or hypercholesterolemia.

In another aspect of the invention, there is provided a method oflowering blood cholesterol level and/or blood glucose in a mammal,including human, in need of such a treatment comprising administering tosaid mammal an effective amount of a composition according to theinvention. Hereinafter the terms “lowering blood glucose” refer tolowering the blood glucose to a level of 180 mg/dL or less 2 hours aftermeals. As used herein, “lowering blood cholesterol level” refers to ablood cholesterol lowered to a level of less than 240 mg/dL, morepreferably less than 200 mg/dL, or to a blood LDL cholesterol lowered toless than 190 mg/dL, more preferably less than 160 mg/dL, even morepreferably less than 130 mg/dL.

In another embodiment of the invention, the compositions according tothe invention may be used in the manufacture of a medicament ornutritional formulation for the prevention or treatment of metabolicsyndrome and/or diabetes and/or hypercholesterolemia in mammal,including human.

In a further embodiment of the invention, the compositions according tothe invention may be used in the manufacture of a medicament ornutritional formulation for lowering blood glucose and/or bloodcholesterol level in mammal.

According to the invention, the compositions of the invention may beused in meeting the dietary fiber intake of a mammal.

In one aspect of the invention, the method of treatment as hereindescribed may comprise the combined administration with diabetesmedicines, such as sulfonylureas, biguanides, alpha-glucosidaseinhibitors, thiazolidinediones, meglitinides or D-phenylalamine, and/orblood cholesterol lowering medicines, such as statins, bile acidsequestrants, nicotinic acid and fibric acids.

According to the invention, a low viscous composition comprising viscoussoluble fiber may be produced by admixing such a viscous soluble fiberand a viscosity-lowering protein selected from the group consisting ofwheat protein, egg protein, collagen, whey protein, casein, soy protein,pea protein, muscle protein, fibrillar protein, silk proteins, e.g.keratin, sericin or fibroin, gluten and mixtures thereof, morepreferably from the group consisting of wheat protein, egg protein,collagen, whey protein, casein and mixtures thereof, in an aqueousmedium under conditions sufficient to form a non-viscous composition,e.g. a composition which has a viscosity lower than the viscosity of thesame composition in which the viscosity-lowering protein is absent.Suitable examples of aqueous medium include, but are not limited to,water, milk water-based beverages, milk-based beverages, carbonatedbeverage, non-carbonated beverage, beer, wine, soy milk and fruit-basedbeverage, like orange juice. Such aqueous medium may also includespecific buffers, like phosphate buffer.

According to the invention, the ingredients may be added simultaneouslyor sequentially, i.e. the viscosity-lowering protein followed orpreceded by the viscous soluble fiber, to the aqueous medium, as definedabove.

In one embodiment of the invention, the ingredients of the compositionsof the invention may be added in dry form, i.e. as a dry blend ofviscous soluble fiber and viscosity-lowering protein. Such a dry blendmay be dispersed into an aqueous medium by stirring or mixing,preferably using cold, hot or boiling aqueous medium, and morepreferably using aqueous medium at a temperature of about 5° C. to about35° C. In one aspect of the invention the composition of the inventionin form of a drink may be obtained by dispersing the blend, e.g. dryblend, of viscous soluble fiber and viscosity-lowering protein in coldwater, e.g. water at a temperature of between about 5 and about 35° C.

In another embodiment of the invention, the dried ingredients of thecompositions of the invention may be hydrated separately before beingmixed, i.e. a dispersion of soluble viscous fiber and/or a dispersion ofviscosity-lowering protein may be prepared separately and then mixed.Suitable techniques of hydrating viscous soluble fibers and obtainingsuch dispersions are known in the art. The conditions chosen, such astemperature or stirring time, for hydrating the viscous soluble fiberwill depend in particular on the nature and concentration of the fiber.Such conditions are known in the art. To obtain a hydrated solubleviscous fiber dispersion, the soluble viscous fiber may be added to acold, hot or boiling aqueous medium, more preferably to an aqueousmedium at a temperature from about 70° C. to about 80° C., and stirredfor one to several hours, for example for 1 hour. Preferably, theconcentration of the soluble viscous fiber in the dispersion will varyfrom about 0.05 to about 15% by weight, more preferably from about 0.5to about 5% by weight, based on the total weight of the dispersion. Inone embodiment of the invention, the soluble viscous fiber dispersionmay be prepared in a phosphate buffer, e.g. at a pH from about 6.7 toabout 7.2. Lower pH values may also be used, e.g. a pH from about 3.8 toabout 5.7. For example, a konjac gum dispersion may be prepared byadding konjac flour in an amount of from about 0.5 to about 5% byweight, based on the total weight of the dispersion, to a phosphatebuffer solution, having a pH from about 6.7 to about 7.2, at roomtemperature, and by stirring for approximately 5 minutes. The hydratedviscosity-lowering protein dispersion may be prepared by hydrating thedry viscosity-lowering protein in an aqueous medium at room temperature.The concentration of the viscosity-lowering protein in the dispersionmay vary from about 0.1 to about 60% by weight, preferably from about0.5 to about 35%, more preferably from about 1 to about 10% by weight,based on the total weight of the dispersion. For example, collagenhydrolysate dispersion may be prepared by stirring for less than 5minutes in a cold aqueous medium.

In a further embodiment of the invention, the dried soluble viscousfiber may be added to a viscosity-lowering protein dispersion, e.g.hydrated protein, or the dried viscosity-lowering protein may be addedto a soluble viscous fiber dispersion. In either case, the driedcomponent is added to a dispersion at a low temperature, at roomtemperature or at a high temperature, for example from about 5° C. toabout 60° C., more preferably from about 15° C. to about 25° C.

According to the invention, the concentration of soluble viscous fibermay vary from about 0.05 to about 30% by weight, preferably from about0.1 to about 10% by weight, more preferably from about 0.5 to about 5%by weight, and even more preferably from about 0.75% to about 2% byweight, based on the total weight of the composition. The concentrationof the viscosity-lowering protein may be from about 1 to about 60% byweight, preferably from about 2 to about 20% by weight, more preferablyfrom about 3 to about 10% by weight, even more preferably from about 4to about 8% by weight, based on the total weight of the composition. Ina further step, the composition of the invention may be dehydrated toobtain a powder.

It will be appreciated that the suitable method of dispersion will bechosen based on the desired properties and/or uses of the compositionsof the invention.

According to the invention, the viscosity of the compositions of theinvention may be modulated, for example re-increased. In one embodimentof the invention, there is provided a method to modulate and/or delay,preferably re-increase, the viscosity of the non-viscous compositions ofthe invention, by modulating and/or delaying the degradation state ofthe viscosity-lowering protein. The more viscosity-lowering protein isdegraded, e.g. denatured or hydrolyzed, the less is its effect onlowering the viscosity, and the more the viscosity re-increases.Suitable methods of denaturizing or hydrolyzing proteins are known inthe art. For example, the viscosity-lowering proteins of thecompositions of the invention may be denatured or hydrolyzed byproteases, such as pepsin, trypsin, chymotrypsin, exopeptidase orendopeptidase, at a temperature from about 20° C. to about 60° C.,preferably at about 37° C. Optionally, the viscosity of the compositionsof the invention, e.g. non-viscous or low-viscous compositions, may bere-increased by heating and simultaneously using an alkaline treatment,e.g. at a pH of about 12, or more preferably by using an acidictreatment, e.g. at a pH of about 4.5, more preferably at a pH below 2.Various degrees of modulation of the viscosity of the compositions ofthe invention may be obtained by varying the degree of denaturation orhydrolysis, e.g. the hydrolysis conditions, such as for exampletemperature, incubation period, nature of enzyme and/or pH. Acombination of two or more denaturation or hydrolysis methods, e.g. ofenzymatic and acid hydrolysis, may also be used. In one embodiment ofthe invention, the compositions of the invention may be incubated in thepresence of a protease under conditions and time sufficient to denatureor hydrolyze the viscosity-lowering protein to the extent that it has nofurther viscosity lowering activity, e.g. no longer suppresses theviscosity of the viscous soluble fiber.

In a further aspect of the invention, there is provided a method ofdenaturizing or hydrolyzing the viscosity-lowering protein(s) tore-increase or reverse the viscosity of a composition of the invention,which method comprises the addition of means, such as proteases, e.g.pepsin, trypsin, chymotrypsin, exopeptidase or endopeptidase, in amountssufficient to induce degradation, e.g. denaturation or hydrolysis, ofthe viscosity-lowering-protein(s), as well as acidic or basic solutionsin amounts sufficient to decrease or increase, respectively, the pH ofthe composition of the invention, to the composition of the invention.

In yet a further aspect there is provided a use of means as hereinabovedescribed for denaturizing or hydrolyzing the viscosity-loweringprotein(s) to re-increase or reverse the viscosity of a composition ofthe invention.

The utility of all the compositions of the present invention may beobserved in standard clinical tests in, for example, indications ashereinabove described, for example using daily dosages of viscoussoluble fiber in the range of about 2 mg, 25 mg, 50 mg or 2 g to about20, 30, 40 or 50 g, and viscosity lowering protein in dosages sufficientto provide a non-viscous composition of the invention, for a mammal,e.g. adult and in standard animal models. The blood glucose loweringeffect or blood cholesterol lowering effect may be observed in standardanimal tests and in clinical trials.

One human clinical trial may be affected as follows:

A single blind, placebo controlled, parallel study in 90 subjects may beperformed using the composition of the invention, e.g. comprising about2 mg, 25 mg, 50 mg or 2 g to about 20, 30, 40 or 50 g viscous solublefiber and viscosity lowering protein in dosages sufficient to provide anon-viscous composition of the invention, to study the effects onmetabolic syndrome characteristics. The following parameters may beassessed at baseline and after 3 month of treatment body weight, weightregain and composition of weight regain, attitude towards eating,appetite profile, oral glucose tolerance (OGT), glucose, insulin,C-peptide, triglyceride (TG), Glycerol, free fatty acids (FFA) andsatiety (all subjects).

According to the invention it is possible to effectively amelioratesymptoms and conditions associated with metabolic syndrome, diabetes orhigh blood cholesterol levels with natural compounds, which do not showany severe side effects. Further, the present methods are well-toleratedand simple to apply.

The invention is further illustrated with reference to the followingExamples.

EXAMPLES

Konjac gum is from Propol RS, Shimizu, Japan.

Collagen hydrolysate is from Collagel A, Deutsche Gelatine-FabrikenStoess & Co GmbH, Germany.

High MW Guar type is from Polygum 75, Polygal AG, Switzerland.

Low MW Guar type is from Lygomme 3, Degussa Texturant Systems, France.

Xanthan gum is from Satiaxane CX2QD, Degussa Texturant System, France.

Aspartame is from Searle, USA (Nutrasweet™).

Acesulfam K is from Nutrinova, Germany (Sunett™).

Example 1 Influence of Viscosity-Lowering Protein on a 1% Konjac GumComposition

The konjac gum and the viscosity-lowering protein are admixed togetherand dispersed in water at temperature of about 25° C. A magneticagitation is used as dispersion tools and the mixing is kept for 2 min.After 1 hour standing time the viscosity is measured. Molecular ProteinFinal Weight Protein Konjac Solution Solution Protein (kDa) Content⁽¹⁾Content⁽¹⁾ Viscosity* Viscosity** Glycin 0.1 10 1 <10 >5000 Wheat <1 101 <10 200 Egg  3-10 10 1 50 250 Collagen 10-18 10 1 10 60 Whey 10-18 101 25 500 — — — 1 — >5000⁽¹⁾% by weight, based on the total weight of the composition.*Viscosity (mPa · s) measured with a Brookfield viscometer (LVDV number1 spindle, 60 rpm).**Viscosity (mPa · s) measured with a Brookfield viscometer (LVDV number4 spindle, 60 rpm) after 30 minutes of standing time.

Example 2 Influence of the Collagen Concentration on the Viscosity of a1% Konjac Gum Composition

Compositions comprising konjac gum and collagen hydrolysate at differentconcentrations were prepared as described in Example 1, and theirviscosities were measured at 25° C. with a Brookfield viscometer using aLVDV number 4 spindle and a shear rate of 60 rpm Konjac gum⁽¹⁾ 1 1 1 1 1Collagen⁽¹⁾ 10 6.5 5 3.5 0 Viscosity 60 50 50 90 >5000⁽¹⁾% by weight, based on the total weight of the composition.

Example 3 Influence of Collagen on the Viscosity of Konjac Gum and/orXanthan Gum Compositions

The viscous soluble fiber compositions were prepared as described inExample 1, and their viscosities were measured. Konjac gum⁽¹⁾ — 0.8 0.8—  1 Xanthan gum⁽¹⁾   0.2 0.2 0.2 0.2 — Collagen⁽¹⁾ — — 5   5   —Viscosity (mPa · s) 120** 1500*   400**   15** 7000*⁽¹⁾% by weight, based on the total weight of the composition.*Viscosity measured with a Brookfield viscometer using a LVDV number 4spindle and a shear rate of 60 rpm.**Viscosity measured with a Brookfield viscometer using a LVDV number 2spindle and a shear rate of 60 rpm.

Example 4 Viscosity of Guar Gum Compositions

The compositions were prepared as described in the Example 1. Theviscosities were measured with a Brookfield viscometer with LV spindleat 20° C.

A. Influence of Molecular Weight and Concentration of Guar Gum on theViscosity. High MW guar gum (g) 1 2 3 4 — — — — — Low MW guar gum (g) —— — — 1 2 3 4 5 Water (g) 199 198 197 196 199 198 197 196 195 Viscosity(mPa · s) 330 4100 28000 170000 75 1020 4500 15000 58000

B. Viscosity Lowering Effect of Collagen on Guar Gum Compositions. HighMW guar gum (g) 3.0 3.0 3.0 — — — Low MW guar gum (g) — — — 4.3 4.3 4.3Collagen (g) — 10 15 — 10 15 Water (g) 197 187 182 195.7 185.7 180.7Viscosity (mPa · s) 30600 110 19 31600 240 35

C. Viscosity Lowering Effect of Different Collagen Concentration on theViscosity of a 1.5% by Weight, Guar Gum Composition (High MW Type). Guargum (g) 3 3 3 3 3 3 Collagen (g) 0 2.5 5 7.5 10 15 Water (g) 197 194.5192 189.5 187 182 Viscosity (mPa · s) 31000 26000 5300 110 67 29

Example 5 Viscosity of Xanthan Gum Compositions

The viscous soluble fiber compositions were prepared as described inExample 1, and the viscosities were measured with a Brookfield, spindleLV DV at 20° C.

A. influence of Collagen Concentration on the Viscosity of a 1% byWeight Xanthan Gum Composition. Xanthan gum (g) 2 2 2 2 2 2 Collagen (g)0 2.5 5 7.5 10 15 Water (g) 198 195.5 193 190.5 188 183 Viscosity (mPa ·s) 760 520 3050 6300 30400 41000

B. Influence of Collagen on the Viscosity of Xanthan Gum Compositions.Xanthan gum (g) 0.4 0.4 1 1 2 2 Collagen (g) — 10 — 10 — 10 Water (g)199.6 189.6 199 189 198 188 Viscosity (mPa · s) 120 15 300 2500 76030400

C. Influence of the Acidity on the Viscosity of a 0.5% by Weight XanthanGum Composition. Xanthan gum (g) 1 1 1 1 Collagen (g) 5 10 5 10 Citricacid (g) — — 0.05 0.05 Water (g) 194 189 194 189 pH 5.55 5.55 5.15 5.15Viscosity (mPa · s) 1500 570 280 20

Example 6 Interactions Between Guar Gum and Xanthan Gum

The compositions were prepared as in Example 1. The viscosity wasmeasured with a Brookfield viscosimeter (spindle LV) at 20° C.

A. Effects on the viscosity. Xanthan gum (g) 0 0.3 0.9 1.5 2.1 Guar gum(g) 3 2.7 2.1 1.5 0.9 Water (g) 197 197 197 197 197 Viscosity (mPa · s)49000 212000 60000 6000 2100

B. Influence of Collagen 5% by Weight on the Viscosity. Xanthan gum (g)0 0.3 0.9 1.5 2.1 Guar gum (g) 3 2.7 2.1 1.5 0.9 Collagen (g) 10 10 1010 10 Water (g) 187 187 187 187 187 Viscosity (mPa · s) 100 15000 98000200000 300000

C. Influence of Acidity and Collagen 5% by Weight on the Viscosity.Xanthan gum (g) 0 0.3 0.9 1.5 2.1 Guar gum (g) 3 2.7 2.1 1.5 0.9Collagen (g) 10 10 10 10 10 Citric acid (g) 0.05 0.05 0.05 0.05 0.05Water (g) 187 187 187 187 187 Viscosity 100 1200 200000 320000 340000(mPa · s)

D. Influence of Acidity and Collagen 2.5% by Weight on the Viscosity.Xanthan gum (g) 0 0 0.3 0.3 0.9 0.9 0.9 Guar gum (g) 3 3 2.7 2.7 2.1 2.12.1 Collagen (g) 5 5 5 5 5 5 5 Citric acid (g) 0.025 0.25 0.025 0.250.025 0.25 1 Water (g) 198 198 198 198 198 198 197 Viscosity (mPa · s)100 5000 1200 25000 200000 42600 39000

Example 7 Preparation of a Lemon Instant Drink Containing Guar Gum andCollagen

The different ingredients are admixed together and mixed with 264.4 g ofwater at temperature of about 25° C., in a shaker, for about 10 seconds.Guar gum⁽¹⁾ (g) 3.75 Collagen (g) 17.3 Fructose (g) 12.3Na₂Hpyrophosphate (g) 0.9 Citric acid (g) 0.5 Lemon flavor (g) 0.7Aspartame⁽²⁾ (g) 0.015 Acesulfam K⁽³⁾ (g) 0.015 Acetic ester of mono anddiglycerides (g) 0.08⁽¹⁾The guar gum is of high molecular weight type.

The final composition has a pH of 4.35 and a viscosity between about 25and about 30 mPa·s.

1-18. (canceled)
 19. Use of a protein to modulate the viscosity of acomposition comprising one or more viscous soluble fiber(s), whereinsaid protein is at least one of wheat protein, egg protein, collagen,whey protein, casein, soy protein, pea protein, muscle protein, gluten,fibrillar protein, silk proteins, and 5 hydrolysates thereof.
 20. Theuse according to claim 19, wherein said viscous soluble fiber is atleast one of gum, pectin, beta-glucan, mucilage, and carrageenan. 21.The use according to claim 20, wherein said gum is at least one ofkonjac gum, locust bean gum, tare bean gum, gum tragacanth, karaya gum,xanthan gum, arable gum, guar gum, and gellan gum.
 22. A composition fororal or enteral administration comprising one or more viscous solublefiber(s) and one or more viscosity-lowering protein(s).
 23. Thecomposition of claim 22 having a viscosity of less than about 500 mPa·sat room temperature.
 24. The composition of claim 22 wherein the ratioof said fiber:said protein is from about 0.01:1 to about 20:1.
 25. Thecomposition of claims 22 comprising about 1% to about 10% by weight ofviscous soluble fibers, based on the total weight of the composition.26. The composition of claim 22 wherein said fiber is at least one ofgum, mucilage, carrageenan, pectin, and beta-glucan.
 27. The compositionof claim 26 wherein said gum is at least one of konjac gum, locust beangum, tare bean gum, gum tragacanth, karaya gum, xanthan gum, arabic gum,guar gum, and gellan gum.
 28. The composition of claim 22 wherein thecomposition is in form of a drink.
 29. Use of a composition of claim 22for the manufacture of a medicament or nutritional composition for theprevention or treatment of metabolic syndrome and/or diabetes and/or forlowering blood cholesterol level.
 30. A non-viscous composition for oralor enteral administration comprising one or more viscous solublefiber(s) and one or more viscosity-lowering protein(s).
 31. Thecomposition of claim 30 having a viscosity of less than about 500 mPa·sat room temperature.
 32. The composition of claim 30 wherein the ratioof said fiber:said protein is from about 0.01:1 to about 20:1.
 33. Thecomposition of claims 30 comprising about 1% to about 10% by weight ofviscous soluble fibers, based on the total weight of the composition.34. The composition of claim 30 wherein said protein is at least one ofwheat protein, egg protein, collagen, whey protein, casein, soy protein,pea protein, muscle protein, gluten, fibrillar protein, silk protein,and hydrolysates thereof.
 35. The composition of claim 30 wherein saidfiber is at least one of gum, mucilage, carrageenan, pectin, andbeta-glucan.
 36. The composition of claim 35 wherein said gum is atleast one of konjac gum, locust bean gum, tare bean gum, gum tragacanth,karaya gum, xanthan gum, arabic gum, guar gum, and gellan gum.
 37. Thecomposition of claim 30 wherein the composition is in form of a drink.38. Use of a composition of claim 30 for the manufacture of a medicamentor nutritional composition for the prevention or treatment of metabolicsyndrome and/or diabetes and/or for lowering blood cholesterol level.39. A composition comprising one or more viscous soluble fiber(s) andone or more viscosity lowering protein(s) wherein the viscous solublefiber is at least one of gum, mucilage, carrageenan, pectin, andbeta-glucan, and the viscosity-lowering protein is at least one of wheyprotein, soy protein, and hydrolysates thereof.
 40. The composition ofclaim 39 wherein the composition is in form of a drink.
 41. Use of acomposition of claim 39 for the manufacture of a medicament ornutritional composition for the prevention or treatment of metabolicsyndrome and/or diabetes and/or for lowering blood cholesterol level.42. A composition comprising one or more viscous soluble fiber(s) andone or more viscosity lowering protein(s) wherein the viscosity-loweringprotein is at least one of wheat protein, egg protein, collagen, muscleprotein, gluten, fibrillar protein, silk protein, and hydrolysatesthereof.
 43. The composition of claim 42 wherein the composition is inform of a drink.
 44. Use of a composition of claim 42 for themanufacture of a medicament or nutritional composition for theprevention or treatment of metabolic syndrome and/or diabetes and/or forlowering blood cholesterol level.
 45. A composition comprising one ormore viscous soluble fiber(s) and one or more viscosity loweringprotein(s) wherein the viscosity-lowering protein is at least one ofwhey protein, soy protein, pea protein, and hydrolysates thereof, withthe proviso that the composition does not comprise inulin.
 46. Thecomposition of claim 45 wherein the composition is in form of a drink.47. Use of a composition of claim 45 for the manufacture of a medicamentor nutritional composition for the prevention or treatment of metabolicsyndrome and/or diabetes and/or for lowering blood cholesterol level.48. A method of treating and/or preventing metabolic syndrome and/ordiabetes, and/or of lowering blood cholesterol level in a mammal in needof such a treatment comprising administering to said mammal an effectiveamount of a composition selected from the group consisting of: a) Acomposition for oral or enteral administration comprising one or moreviscous soluble fiber(s) and one or more viscosity-lowering protein(s);b) A composition for oral or enteral administration comprising one ormore viscous soluble fiber(s) and one or more viscosity-loweringprotein(s), said composition having a viscosity of less than about 500mPa·s at room temperature; c) A composition for oral or enteraladministration comprising one or more viscous soluble fiber(s) and oneor more viscosity-lowering protein(s), said composition having a ratioof said fiber:said protein is from about 0.01:1 to about 20:1; d) Acomposition for oral or enteral administration comprising one or moreviscous soluble fiber(s) and one or more viscosity-lowering protein(s),said composition having about 1% to about 10% by weight of viscoussoluble fibers, based on the total weight of the composition; e) Acomposition for oral or enteral administration comprising one or moreviscous soluble fiber(s) and one or more viscosity-lowering protein(s),wherein said fiber is at least one of gum, mucilage, carrageenan,pectin, and beta-glucan; f) A composition for oral or enteraladministration comprising one or more viscous soluble fiber(s) and oneor more viscosity-lowering protein(s), wherein said fiber is at leastone of gum, mucilage, carrageenan, pectin, and beta-glucan and whereinsaid gum is at least one of konjac gum, locust bean gum, tare bean gum,gum tragacanth, karaya gum, xanthan gum, arabic-gum, guar gum, andgellan gum; g) A composition for oral or enteral administrationcomprising one or more viscous soluble fiber(s) and one or moreviscosity-lowering protein(s), wherein the composition is in form of adrink; h) A composition for oral or enteral administration comprisingone or more viscous soluble fiber(s) and one or more viscosity-loweringprotein(s), for a medicament or nutritional composition for theprevention or treatment of metabolic syndrome and/or diabetes and/or forlowering blood cholesterol level; i) A non-viscous composition for oralor enteral administration comprising one or more viscous solublefiber(s) and one or more viscosity-lowering protein(s); j) A non-viscouscomposition for oral or enteral administration comprising one or moreviscous soluble fiber(s) and one or more viscosity-lowering protein(s),said composition having a viscosity of less than about 500 mPa·s at roomtemperature; k) A non-viscous composition for oral or enteraladministration comprising one or more viscous soluble fiber(s) and oneor more viscosity-lowering protein(s) wherein the ratio of saidfiber:said protein is from about 0.01:1 to about 20:1; l) A non-viscouscomposition for oral or enteral administration comprising one or moreviscous soluble fiber(s) and one or more viscosity-lowering protein(s)comprising about 1% to about 10% by weight of viscous soluble fibers,based on the total weight of the composition; m) A non-viscouscomposition for oral or enteral administration comprising one or moreviscous soluble fiber(s) and one or more viscosity-lowering protein(s)wherein said protein is at least one of wheat protein, egg protein,collagen, whey protein, casein, soy protein, pea protein, muscleprotein, gluten, fibrillar protein, silk protein, and hydrolysatesthereof; n) A non-viscous composition for oral or enteral administrationcomprising one or more viscous soluble fiber(s) and one or moreviscosity-lowering protein(s) wherein said fiber is at least one of gum,mucilage, carrageenan, pectin, and beta-glucan; o) A non-viscouscomposition for oral or enteral administration comprising one or moreviscous soluble fiber(s) and one or more viscosity-lowering protein(s)wherein said gum is at least one of konjac gum, locust bean gum, tarebean gum, gum tragacanth, karaya gum, xanthan gum, arabic gum, guar gum,and gellan gum; p) A non-viscous composition for oral or enteraladministration comprising one or more viscous soluble fiber(s) and oneor more viscosity-lowering protein(s) wherein the composition is in formof a drink; q) A non-viscous composition for oral or enteraladministration comprising one or more viscous soluble fiber(s) and oneor more viscosity-lowering protein(s) for the manufacture of amedicament or nutritional composition for the prevention or treatment ofmetabolic syndrome and/or diabetes and/or for lowering blood cholesterollevel; r) A composition comprising one or more viscous soluble fiber(s)and one or more viscosity lowering protein(s) wherein the viscoussoluble fiber is at least one of gum, mucilage, carrageenan, pectin, andbeta-glucan, and the viscosity-lowering protein is at least one of wheyprotein, soy protein, and hydrolysates thereof; s) A compositioncomprising one or more viscous soluble fiber(s) and one or moreviscosity lowering protein(s) wherein the viscous soluble fiber is atleast one of gum, mucilage, carrageenan, pectin, and beta-glucan, andthe viscosity-lowering protein is at least one of whey protein, soyprotein, and hydrolysates thereof wherein the composition is in form ofa drink; t) A composition comprising one or more viscous solublefiber(s) and one or more viscosity lowering protein(s) wherein theviscous soluble fiber is at least one of gum, mucilage, carrageenan,pectin, and beta-glucan, and the viscosity-lowering protein is at leastone of whey protein, soy protein, and hydrolysates thereof for amedicament or nutritional composition for the prevention or treatment ofmetabolic syndrome and/or diabetes and/or for lowering blood cholesterollevel; u) A composition comprising one or more viscous soluble fiber(s)and one or more viscosity lowering protein(s) wherein theviscosity-lowering protein is at least one of wheat protein, eggprotein, collagen, muscle protein, gluten, fibrillar protein, silkprotein, and hydrolysates thereof; v) A composition comprising one ormore viscous soluble fiber(s) and one or more viscosity loweringprotein(s) wherein the viscosity-lowering protein is at least one ofwheat protein, egg protein, collagen, muscle protein, gluten, fibrillarprotein, silk protein, and hydrolysates thereof wherein the compositionis in form of a drink; w) A composition comprising one or more viscoussoluble fiber(s) and one or more viscosity lowering protein(s) whereinthe viscosity-lowering protein is at least one of wheat protein, eggprotein, collagen, muscle protein, gluten, fibrillar protein, silkprotein, and hydrolysates thereof for a medicament or nutritionalcomposition for the prevention or treatment of metabolic syndrome and/ordiabetes and/or for lowering blood cholesterol level; x) A compositioncomprising one or more viscous soluble fiber(s) and one or moreviscosity lowering protein(s) wherein the viscosity-lowering protein isat least one of whey protein, soy protein, pea protein, and hydrolysatesthereof, with the proviso that the composition does not comprise inulin;and y) A composition comprising one or more viscous soluble fiber(s) andone or more viscosity lowering protein(s) wherein the viscosity-loweringprotein is at least one of whey protein, soy protein, pea protein, andhydrolysates thereof, with the proviso that the composition does notcomprise inulin wherein the composition is in form of a drink.
 49. Themethod of claim 48, wherein said mammal is a human.
 50. A method forproviding viscous soluble fibers to a mammal in need of such fiberscomprising administering to said mammal a composition selected from thegroup consisting of: a) A composition for oral or enteral administrationcomprising one or more viscous soluble fiber(s) and one or moreviscosity-lowering protein(s); b) A composition for oral or enteraladministration comprising one or more viscous soluble fiber(s) and oneor more viscosity-lowering protein(s), said composition having aviscosity of less than about 500 mPa·s at room temperature; c) Acomposition for oral or enteral administration comprising one or moreviscous soluble fiber(s) and one or more viscosity-lowering protein(s),said composition having a ratio of said fiber:said protein is from about0.01:1 to about 20:1; d) A composition for oral or enteraladministration comprising one or more viscous soluble fiber(s) and oneor more viscosity-lowering protein(s), said composition having about 1%to about 10% by weight of viscous soluble fibers, based on the totalweight of the composition; e) A composition for oral or enteraladministration comprising one or more viscous soluble fiber(s) and oneor more viscosity-lowering protein(s), wherein said fiber is at leastone of gum, mucilage, carrageenan, pectin, and beta-glucan; f) Acomposition for oral or enteral administration comprising one or moreviscous soluble fiber(s) and one or more viscosity-lowering protein(s),wherein said fiber is at least one of gum, mucilage, carrageenan,pectin, and beta-glucan and wherein said gum is at least one of konjacgum, locust bean gum, tare bean gum, gum tragacanth, karaya gum, xanthangum, arabic gum, guar gum, and gellan gum; g) A composition for oral orenteral administration comprising one or more viscous soluble fiber(s)and one or more viscosity-lowering protein(s), wherein the compositionis in form of a drink; h) A composition for oral or enteraladministration comprising one or more viscous soluble fiber(s) and oneor more viscosity-lowering protein(s), for a medicament or nutritionalcomposition for the prevention or treatment of metabolic syndrome and/ordiabetes and/or for lowering blood cholesterol level; i) A non-viscouscomposition for oral or enteral administration comprising one or moreviscous soluble fiber(s) and one or more viscosity-lowering protein(s);j) A non-viscous composition for oral or enteral administrationcomprising one or more viscous soluble fiber(s) and one or moreviscosity-lowering protein(s), said composition having a viscosity ofless than about 500 mPa·s at room temperature; k) A non-viscouscomposition for oral or enteral administration comprising one or moreviscous soluble fiber(s) and one or more viscosity-lowering protein(s)wherein the ratio of said fiber:said protein is from about 0.01:1 toabout 20:1; l) A non-viscous composition for oral or enteraladministration comprising one or more viscous soluble fiber(s) and oneor more viscosity-lowering protein(s) comprising about 1% to about 10%by weight of viscous soluble fibers, based on the total weight of thecomposition; m) A non-viscous composition for oral or enteraladministration comprising one or more viscous soluble fiber(s) and oneor more viscosity-lowering protein(s) wherein said protein is at leastone of wheat protein, egg protein, collagen, whey protein, casein, soyprotein, pea protein, muscle protein, gluten, fibrillar protein, silkprotein, and hydrolysates thereof; n) A non-viscous composition for oralor enteral administration comprising one or more viscous solublefiber(s) and one or more viscosity-lowering protein(s) wherein saidfiber is at least one of gum, mucilage, carrageenan, pectin, andbeta-glucan; o) A non-viscous composition for oral or enteraladministration comprising one or more viscous soluble fiber(s) and oneor more viscosity-lowering protein(s) wherein said gum is at least oneof konjac gum, locust bean gum, tare bean gum, gum tragacanth, karayagum, xanthan gum, arabic gum, guar gum, and gellan gum; p) A non-viscouscomposition for oral or enteral administration comprising one or moreviscous soluble fiber(s) and one or more viscosity-lowering protein(s)wherein the composition is in form of a drink; q) A non-viscouscomposition for oral or enteral administration comprising one or moreviscous soluble fiber(s) and one or more viscosity-lowering protein(s)for the manufacture of a medicament or nutritional composition for theprevention or treatment of metabolic syndrome and/or diabetes and/or forlowering blood cholesterol level; r) A composition comprising one ormore viscous soluble fiber(s) and one or more viscosity loweringprotein(s) wherein the viscous soluble fiber is at least one of gum,mucilage, carrageenan, pectin, and beta-glucan, and theviscosity-lowering protein is at least one of whey protein, soy protein,and hydrolysates thereof; s) A composition comprising one or moreviscous soluble fiber(s) and one or more viscosity lowering protein(s)wherein the viscous soluble fiber is at least one of gum, mucilage,carrageenan, pectin, and beta-glucan, and the viscosity-lowering proteinis at least one of whey protein, soy protein, and hydrolysates thereofwherein the composition is in form of a drink; t) A compositioncomprising one or more viscous soluble fiber(s) and one or moreviscosity lowering protein(s) wherein the viscous soluble fiber is atleast one of gum, mucilage, carrageenan, pectin, and beta-glucan, andthe viscosity-lowering protein is at least one of whey protein, soyprotein, and hydrolysates thereof for a medicament or nutritionalcomposition for the prevention or treatment of metabolic syndrome and/ordiabetes and/or for lowering blood cholesterol level; u) A compositioncomprising one or more viscous soluble fiber(s) and one or moreviscosity lowering protein(s) wherein the viscosity-lowering protein isat least one of wheat protein, egg protein, collagen, muscle protein,gluten, fibrillar protein, silk protein, and hydrolysates thereof; v) Acomposition comprising one or more viscous soluble fiber(s) and one ormore viscosity lowering protein(s) wherein the viscosity-loweringprotein is at least one of wheat protein, egg protein, collagen, muscleprotein, gluten, fibrillar protein, silk protein, and hydrolysatesthereof wherein the composition is in form of a drink; w) A compositioncomprising one or more viscous soluble fiber(s) and one or moreviscosity lowering protein(s) wherein the viscosity-lowering protein isat least one of wheat protein, egg protein, collagen, muscle protein,gluten, fibrillar protein, silk protein, and hydrolysates thereof for amedicament or nutritional composition for the prevention or treatment ofmetabolic syndrome and/or diabetes and/or for lowering blood cholesterollevel; x) A composition comprising one or more viscous soluble fiber(s)and one or more viscosity lowering protein(s) wherein theviscosity-lowering protein is at least one of whey protein, soy protein,pea protein, and hydrolysates thereof, with the proviso that thecomposition does not comprise inulin; and y) A composition comprisingone or more viscous soluble fiber(s) and one or more viscosity loweringprotein(s) wherein the viscosity-lowering protein is at least one ofwhey protein, soy protein, pea protein, and hydrolysates thereof, withthe proviso that the composition does not comprise inulin wherein thecomposition is in form of a drink.
 51. The method of claim 50, whereinsaid mammal is a human.